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Weekly Drug News Round Up - September 25, 2013

FDA Communication: New Boxed Warning for Arzerra and Rituxan

HBV reactivation has occurred in patients with prior HBV exposure who are later treated with these monoclonal antibodies Read More…

The U.S. Food and Drug Administration (FDA) has approved updates to the prescribing information for Arzerra (ofatumumab) and Rituxan (rituximab), two drugs used to suppress the immune system and fight cancer; Rituxan is also used to treat rheumatoid arthritis. Updates include new Boxed Warning information about the risk of reactivation of hepatitis B virus (HBV) infection, which may lead to fulminant hepatitis, hepatic failure, and death. In addition, all patients should be screened for HBV infection before starting treatment with Arzerra or Rituxan. The revised labels will also include additional recommendations for monitoring and managing patients on these drugs to decrease the risks.

Package Changes for Fentanyl Patches to Decrease Accidental Exposure

To dispose of used fentanyl patches: fold the patch, sticky sides together, and then flush it down the toilet immediately Read More...

Duragesic (fentanyl transdermal) patch is a potent prescription pain medicine that contains a narcotic opioid; it is also marketed in generic versions. Accidental exposure to these patches can cause serious harm and death in children, pets, and others. The patches may fall off of patients and may not be easily seen. To help remedy this situation, U.S. Food and Drug Administration (FDA) is requiring manufacturers to print the name and strength of the drug on the patch in a long-lasting colored ink that is clearly visible to patients and caregivers. The colored ink should increase the likelihood that patches on the body or that have fallen off can be seen and disposed of properly by flushing down the toilet.

Janssen Biotech's Stelara FDA-Approved to Treat Active Psoriatic Arthritis

The approved treatment dose is a 45 mg injection of Stelara at weeks 0 and 4, then once every 12 weeks thereafter Read More...

The U.S. Food and Drug Administration (FDA) has approved Stelara (ustekinumab) alone or in combination with methotrexate for the treatment of adult patients with psoriatic arthritis. Psoriatic arthritis is form of arthritis characterized by both joint inflammation and psoriasis skin lesions. Stelara, also approved for use in plaque psoriasis, blocks interleukin-12 and interleukin-23 cytokines to reduce inflammation. In Phase 3 clinical trials, 42 to 50 percent of patients receiving Stelara achieved at least a 20 percent improvement at week 24 in the ACR 20, the primary endpoint. The safety profile of Stelara in psoriatic arthritis trials was similar to that seen in plaque psoriasis trials.

Statins Linked with Higher Risk of Developing Cataracts

Another report suggests that the widely popular statin drugs used to lower cholesterol may also increase the risk of developing cataracts Read More...

Cataracts of the eyes, common in seniors, are a clouding of the lens that makes it difficult to read or drive. A nine year retrospective study, published in JAMA Ophthalmology, looked at over 14,000 people, half of whom were taking statins, for example, simvastatin or atorvastatin. Those taking statins had a 27 percent increased risk of developing cataracts compared with nonusers, according to researchers. However, according to some experts, patients should continue statins, as they reduce the risk of potentially fatal heart conditions, and cataract surgery is effective with few complications. A randomized, blinded, controlled clinical trial could solve the debate, but it would be unethical to take patients off of statins.

American Psychiatric Association Releases Antipsychotic Use Recommendations

The list should help patients and physicians start important conversations about antipsychotic treatment options Read More...

The American Psychiatric Association (ACA) has released a list of antipsychotic medication uses that are common, but potentially unnecessary and possibly harmful. The list is not intended to preclude the use of antipsychotic medications, instead it is meant to help doctor and patient make informed choices about antipsychotic drug use, and to encourage a discussion of other treatment options. For example, one recommendation states not to routinely prescribe two or more antipsychotic medications, for example - olanzapine (Zyprexa) and risperidone (Risperdal) - at the same time. To view the complete APA list and additional detail about the recommendations and evidence supporting them, also visit